Globally, Nigeria has the 2nd largest number of: a) people living with HIV, b) new HIV infections, and c) pregnant women living with HIV. In 2013 only 17.1% of women of childbearing age 15-49 years received an HIV test (preceding 12-months) and only 27% of the estimated 190,000 HIV-infected pregnant women in Nigeria who delivered babies received antiretroviral therapy for prevention of mother-to-child HIV transmission (PMTCT), compared to 68% of pregnant women receiving ART overall in sub-Saharan Africa (SSA). Nigeria accounts for 25% of new childhood HIV infections among the 21 priority countries (estimated 51,000 new infections). Roughly 49% of HIV-infected pregnant women in SSA are lost to follow up between registration in antenatal care and delivery, and 45% of infants are lost after HIV testing. Nigeria has high loss to follow-up (15%-56%) among HIV-infected women and children. In 2014, we demonstrated that the Healthy Beginning Initiative (HBI), a congregation-based intervention delivered by church-based health teams, was more effective in increasing HIV testing among pregnant women compared to a clinic-based approach. HBI uses church organized baby showers to engage and identify women early in pregnancy, combines educational intervention with integrated, on-site laboratory testing designed to reduce stigma associated with HIV-only testing. Baby receptions facilitate post-delivery follow-up and linkage to care. HBI addresses several barriers to HIV testing: perception of low risk to infection (education), access to testing and treatment, and cost and stigma (on-site, free, integrated testing). At least one faith-based institution is in each community, presenting a unique opportunity to evaluate the effectiveness of iSTAR, an integrated community and clinic based intervention that is designed to test, link, engage and sustain HIV-infected women in care. We propose a cluster randomized comparative effectiveness trial of iSTAR versus a clinic-based approach (CG). We will assess linkage, engagement, retention and viral suppression among 400 HIV-infected women. Based on the EPIS framework, we will use social network intervention methods to facilitate implementation and also assess implementation leadership and context. Fifty churches in south-south Nigeria will be randomly assigned (1:1) to iSTAR or CG. The iSTAR intervention provides: confidential, onsite integrated laboratory testing during baby showers; a network of church-based health advisors; clinic based teams trained in motivational interviewing; quality improvement skills to engage and support HIV-infected women; and integrated case management to reduce loss to follow-up. Primary outcomes are difference in linkage and engagement rates between iSTAR and CG. Secondary outcomes are difference in retention and viral suppression rate. This proposal is a collaboration among University of Nigeria (PEPFAR-funded partner in Nigeria [training and local project oversight]; University of Southern California (network analysis); UC San Diego (implementation science); UIC Chicago (assessment of sustainment); Nevada State College (statistical analyses and mediation/moderation analysis), and University of Nevada, Las Vegas (overall oversight of program implementation and evaluation).
Interventions targeted at increasing the rate of retention and viral load suppression among HIV pregnant women and children are urgently needed to achieve an AIDS free generation. Using a cluster randomized trial design among 400 HIV-infected women followed in 50 churches in Nigeria, the goal of the proposed study is to evaluate the comparative effectiveness of an integrated intervention for sustainable testing and retention (iSTAR) versus clinic-based approach on linkage, engagement, retention and viral suppression rates. Findings from this study will provide policy makers and funding agencies needed information on effective, feasible and sustainable community-based approaches to seek, test, treat and retain individuals with HIV in care.
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